UMIN-CTR Clinical Trial

Basic information
Public title	Physical function through locomotion training a prospective community-based intervention survey
Acronym	Physical function through locomotion training a prospective community-based intervention survey
Scientific Title	Improving physical function through locomotion training a prospective community-based intervention survey
Scientific Title:Acronym	Improving physical function through locomotion training a prospective community-based intervention survey
Region	Japan

Condition
Condition	locomotive syndrome
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to investigate the changes in locomotive functions and health-related quality of life caused by exercises for preventing locomotive syndrome interventions for the elderly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Research subject background: age, gender, medical history, height, weight (health consultation by public health nurses) Health-related QOL questionnaire (EuroQOL, Locomo 25) Daily living pain and mental questionnaires (Oswestry Disability Index, Hospital anxiety and depression scales) Locomo Scan Walking speed (10m walking)
Key secondary outcomes	training days

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	The 110 participants who underwent the gymnastics intervention were divided into three groups according to their locomotor activity according to GLFS-25.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	63 years-old <=
Age-upper limit	94 years-old >
Gender	Male and Female
Key inclusion criteria	1) Those who responded to a questionnaire on health-related QOL 2) Residents aged 60 and over who wish to exercise and obtain written consent
Key exclusion criteria	1) Those who did not respond to the questionnaire on health-related quality of life 2) Residents who do not want to exercise 3) The person in charge of the research or the research coordinator deemed inappropriate to participate in the research
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Yamato
Organization	Department of Orthopedic Surgery, Hamamatsu University School of Medicine
Division name	Division of Geriatric Musculoskeletal Health, Hamamatsu University School of Medicine
Zip code	4313192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL	053-435-2647
Email	yamato@hama-med.ac.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Yamato
Organization	Hamamatsu University School of Medicine
Division name	Department of Orthopedic Surgery, Division of Geriatric Musculoskeletal Health
Zip code	4313192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL	053-435-2647
Homepage URL
Email	yamato@hama-med.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Orthopedic Surgery Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Toei Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
Tel	053-435-2680
Email	rinri@hama-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	110
Results	In the beginning, 117 people were instructed to exercise at a local meeting place and 110 people completed a questionnaire. Since then, the training has been continued every three months. The results of the survey showed that LocoTraining improved locomotive function in subjects with the locomotive syndrome, especially in subjects with locomotive-2 and locomotive-3.
Results date posted	2021 Year 02 Month 21 Day
Results Delayed	Delay expected
Results Delay Reason	The need for reconstruction in the paper.
Date of the first journal publication of results
Baseline Characteristics	65 of 110 elderly people
Participant flow	Exercises every three months for one year.
Adverse events	The start of the COVID-19 epidemic made it temporarily difficult to assemble.
Outcome measures	GLFS-25 EQ5D ODI Walking speed Lower limb extensor strength (using Alcare's LocomoScan)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 02 Month 19 Day
Date of IRB	2019 Year 02 Month 19 Day
Anticipated trial start date	2019 Year 02 Month 19 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The results will be published in an online poster presentation at the Japanese Orthopaedic Association in May 2021. A paper is once rejected, but being reconstructing with the effects of COVID-19.

Management information
Registered date	2020 Year 02 Month 21 Day
Last modified on	2022 Year 08 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045114